ISO
9001:2015 QMS Awareness – Planning
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Change Management For The Quality Management System
Change management is a collective term for all
approaches to prepare, support, and help individuals, teams, and organizations
in making organizational change.
Change management = The management of change
and development within a business or an organization
ISO 9001:2015 QMS standard addresses management
of changes to the quality management system of an organization. Change and
continual improvement are supplementary to each other. In this regard, please
have a look to the following clauses and their requirements:
4.4 – Quality management system and its
processes – Continually improve the quality management system including processes.
5.3 – Top management to assign responsibilities
and authorities for ensuring maintaining integrity of the quality management
system when changes are planned and implemented.
6.3 – Planning of changes – Change planning in
a planned manner by considering purpose of change, potential consequences of
the change, integrity of the quality management system, availability of
resources, allocation / re-allocation of responsibilities and authorities. A
reference to clause 4.4 is also mentioned for planning.
8.1 – Operational planning – (i) Control
planned changes, (ii) Review consequences of unintended (not planned) changes,
and (iii) Taking necessary actions to mitigate (reduce) any adverse effects, as
necessary.
8.3.6 – Design and development changes – Identify,
review and control design and development changes to ensure no adverse impact
to the conformity of product / service.
8.5.6 – Control of changes – Review and control
changes for production / service provision to ensure continuing conformity to
requirements. Retain documented information (= Keep records) describing results
of the review of changes, personnel authorizing changes and any necessary
action arising from the review.
9.2 – Internal audit – Consider importance of
changes during planning, establishing and implementing an audit programme.
9.3 – Management review – Inputs of management
review to consider external and internal issues relevant to the quality
management system. Outputs of management review to take decisions and actions
related to any need for changes to the quality management system.
10.2 – Nonconformity and corrective action – When
a nonconformity occurs, make changes to the quality management system, as
necessary.
Thus, we see that addressing changes becomes an
increasingly important component for the quality management system in ISO
9001:2015 QMS standard.
Changes are part of the system. No one can
avoid changes. Changes may be needed. Changes can be related to any element of
a process. Changes are planned to be beneficial. Changes need to be carried out
as planned. It is better to consider risks and opportunities associated with
the change.
An organization can have a better change
management to achieve the benefits associated with changes. The organization
should consider all types of changes that may need to happen in the
organization’s quality management system. Changes may be generated in
processes, documented information, resources, competence, awareness, operation,
performance evaluation, improvement initiatives, and many more.
Plan-Do-Check-Act (PDCA) methodology will be effective for a successful change
management that may include following steps:
Plan – (i) Define – What need to be changed?
Specific tasks to determine. (ii) Make a plan – How to do? What resources you
need for the change? What information you need? Who will supervise? What will
be the budget? What will be the timeline? Also develop a communication plan,
etc.
Do – Engage people, train them, use resources, make
proper communication and carry out the desired change.
Check – Measure the effectiveness of the
change.
Act – Based on check, correct and improve, if needed.
Think of
the following Questions
(1)
Why change is needed for the quality management
system?
(2)
What changes you may need in the quality
management system of your organization?
(3)
What strategy will you implement for change in
the quality management system?
(4)
What are the requirements of ISO 9001:2015 QMS
standard for Planning of change?
Best wishes,
Keshav Ram Singhal
Please have your comments /
reaction.
To train your employees with ISO
9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN:
B093YFFY7Z), which is available worldwide at Amazon. Please
search this Training Handbook in Amazon Website of your country.
You may also supply your
employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/
(ii) Applying Risk-based Thinking in an Organization Implementing ISO
9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/
Thanks.
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